复宏汉霖K药生物类似药临床研究完成首例受试者给药

HLX17是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规自主研发的帕博利珠单抗注射液生物类似药，经药学比对，临床前药理学、药效学、药代动力学和免疫原性研究证明，HLX17与原研帕博利珠单抗相似。目前帕博利珠单抗已在多个国家和地区获批用于完全切除术后的非小细胞肺癌（NSCLC）、黑色素瘤（MEL）以及肾细胞癌（RCC）患者的辅助治疗等一系列适应症。

HLX17-MRST001是一项多中心、随机、双盲、平行对照的I期临床研究，旨在评估HLX17与KEYTRUDA^®（美国市售）在多种已切除实体肿瘤（包括非小细胞肺癌、黑色素瘤或肾细胞癌）受试者中的药代动力学（PK）特征、有效性、安全性和免疫原性相似性。合格的受试者将按1:1的比例随机分配至A组和B组，A组受试者每3周接受一次HLX17治疗；B组受试者前8个周期（24周）每3周接受一次KEYTRUDA^®治疗，随后转为接受HLX17治疗，所有受试者持续接受治疗至随机化后12个月（约17个周期）或研究者评估的疾病复发、死亡、开始新抗肿瘤治疗、出现不可耐受的药物毒性、撤回知情同意书或研究终止（以先发生者为准）。本研究的主要研究终点为首次给药后从0到21天血清药物浓度-时间曲线下面积（AUC_0-21d）以及第6次给药后稳态下单个给药间隔内的血清药物浓度-时间曲线下面积（AUC_ss）。次要研究终点包括其他PK参数、有效性、安全性和免疫原性。

未来，复宏汉霖将继续聚焦未满足的临床需求，持续拓宽公司在更多疾病领域的前瞻性布局，为全球患者带去高品质、可负担的创新治疗方案。

First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Proposed Pembrolizumab Biosimilar

Shanghai, China, September 26, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject was dosed for a phase 1 multi-centre clinical trial (HLX17-MRST001) of the company's independently developed investigational pembrolizumab biosimilar HLX17 (recombinant anti-PD-1 humanized antibody injection) in China. Previously, the investigational new drug (IND) applications of HLX17-MRST001 have been approved by the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) as an adjuvant therapy for certain resected solid tumors.

HLX17 is a pembrolizumab biosimilar independently developed by Henlius in accordance with the NMPA, EMA, FDA and other international biosimilar guidelines. The pharmacologic comparative study, and preclinical pharmacology study, pharmacodynamics, pharmacokinetics and immunogenicity studies have demonstrated that HLX17 is similar to the reference pembrolizumab. Pembrolizumab has been approved in various countries and regions for a range of different indications, such as for the adjuvant treatment of non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC).

HLX17-MRST001 is a multicenter, randomized, double-blind, parallel-controlled Phase 1 study evaluate the similarity of pharmacokinetic profile, efficacy, safety and immunogenicity of HLX17 vs. KEYTRUDA^® (US-sourced) in patients with multiple resected solid tumors (including non-small cell lung cancer, melanoma, or renal cell carcinoma). Eligible subjects will be randomized in a 1:1 ratio to either Arm A or Arm B, where subjects in Arm A will receive HLX17 once every 3 weeks, and those in Arm B will first receive KEYTRUDA^® once every 3 weeks for 8 cycles (24 weeks) before switching to HLX17 treatment, with all subjects continuing treatment until 12 months after the randomization (nearly 17 cycles), Investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent, or study termination (whichever occurs first). The primary PK endpoints are the area under the serum drug concentration-time curve from time 0 to 21 days (AUC_0-21d) after the first dose and the area under the serum drug concentration-time curve within a dosing interval at steady state (AUC_ss) after the sixth dose. Secondary endpoints include other PK parameters, other efficacy assessments, safety, and immunogenicity.

Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more disease areas, commit to bring high quality and affordable treatments for patients worldwide.

媒体：PR@Henlius.com

投资者：IR@Henlius.com